Important Disclaimer: This information is for educational purposes only and is intended for healthcare professionals. This medication is for hospital or clinical use only and must be administered by a qualified healthcare provider. It is not for self-administration.
ACICLOVIR VIATRIS 250 mg (Powder for Solution for Infusion)
Marketing Authorization Holder: Viatris
Manufacturer: Reig Jofre
Category: Antiviral Agent (Synthetic Nucleoside Analogue)
Active Ingredient per Vial: Acyclovir 250 mg (as Acyclovir Sodium)
Summary
ACICLOVIR VIATRIS is a sterile, intravenous (IV) antiviral medication containing Acyclovir. It is used in a hospital or clinical setting to treat severe or complicated infections caused by the Herpes Simplex Virus (HSV) and Varicella-Zoster Virus (VZV). The intravenous route is chosen when high drug concentrations are needed, when the infection is life-threatening, or when the patient cannot take oral medication.
Mechanism of Action
Acyclovir is a synthetic purine nucleoside analogue. It is selectively converted into its active form, acyclovir triphosphate, only within virus-infected cells by a viral enzyme called thymidine kinase. Acyclovir triphosphate then inhibits viral DNA polymerase, an enzyme essential for viral replication. This action incorporates the drug into the viral DNA chain, leading to chain termination and effectively stopping the virus from multiplying.
Indications
For the treatment of severe viral infections, including:
- Herpes Simplex Encephalitis (HSE).
- Severe initial or recurrent genital herpes in immunocompromised patients.
- Neonatal herpes simplex virus infections.
- Varicella-Zoster (chickenpox/shingles) infections in immunocompromised patients.
- Prophylaxis (prevention) of herpes infections in immunocompromised individuals (e.g., transplant recipients).
Dosage and Administration
Important: This medication must be reconstituted, diluted, and administered intravenously by a healthcare professional. Dosage is highly dependent on the indication, patient's age, weight, and renal function.
- Administration: Given as a slow intravenous infusion over a period of at least 1 hour to prevent renal damage.
- Reconstitution: The powder in the vial is first dissolved with a suitable sterile liquid (like Water for Injections or Sodium Chloride 0.9%) and then further diluted in a larger volume of infusion fluid.
- Hydration: Adequate patient hydration is crucial during and after the infusion to reduce the risk of kidney-related side effects.
Contraindications
Do not use this medication if you have:
- Known hypersensitivity to Acyclovir or Valacyclovir.
Warnings and Precautions
- Renal Impairment: Acyclovir is cleared by the kidneys. The dose must be significantly reduced in patients with renal impairment to prevent toxicity. Kidney function should be monitored.
- Neurological Effects: Reversible neurological side effects (e.g., confusion, hallucinations, agitation, tremors, seizures) can occur, especially in the elderly, those with underlying renal disease, or at high doses.
- Extravasation: The solution is alkaline and can cause severe inflammation and tissue damage if it leaks out of the vein (extravasation). The infusion site must be monitored carefully.
- Hydration: Maintaining good hydration is essential to prevent acyclovir crystals from forming in the renal tubules, which can lead to acute kidney injury.
Possible Side Effects
- Common: Inflammation or phlebitis at the injection site, nausea, vomiting, reversible increases in liver enzymes.
- Less Common: Skin rashes, itching, hives.
- Serious/Rare: Acute renal failure, severe neurological disturbances (encephalopathy), severe allergic reactions (anaphylaxis).
Drug Interactions
- Probenecid: Increases the half-life and plasma concentration of acyclovir.
- Nephrotoxic drugs: Co-administration with other drugs that can harm the kidneys (e.g., cyclosporine, tacrolimus) increases the risk of renal impairment.
Key Professional Information
- The reconstituted solution should be used immediately. Do not refrigerate as this may cause precipitation.
- Check for compatibility with other IV fluids and medications before administration.
- Monitor renal function (e.g., BUN, serum creatinine) and fluid balance, especially in patients at risk.
- Be aware of the potential for neurotoxicity and monitor the patient's mental status.
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